The following data is part of a premarket notification filed by Cooper-hewitt Electric Co. with the FDA for Air Care Air Sanitizer.
Device ID | K860132 |
510k Number | K860132 |
Device Name: | AIR CARE AIR SANITIZER |
Classification | Purifier, Air, Ultraviolet, Medical |
Applicant | COOPER-HEWITT ELECTRIC CO. ARENT,FOX,KINTNER,PLOTKIN,KAHN 1050 CONNECTICUT AVENUE, N. W. Washington, DC 20036 |
Contact | Peter Reichertz |
Correspondent | Peter Reichertz COOPER-HEWITT ELECTRIC CO. ARENT,FOX,KINTNER,PLOTKIN,KAHN 1050 CONNECTICUT AVENUE, N. W. Washington, DC 20036 |
Product Code | FRA |
CFR Regulation Number | 880.6500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-01-14 |
Decision Date | 1987-01-13 |